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Avandia: Who Won?

Posted by: Ken Phelps

Published on: July 15, 2010

The media has been very involved in the Avandia case. Headlines or page 1 stories in the New York Times, Wall Street Journal and the British press seemed to take sides rather than report the facts (okay, I shouldn’t be surprised). Today, the day after the 2-day FDA Advisory Committee met to review the safety concerns about Avandia, we see headlines that generally appear to be aligned with the actual votes:

DIA Website: FDA Panel Votes To Keep Avandia On Market With More Restrictions (no hyperlink since access is by subscription)

Yet, the articles under the headlines take very different views. For example, the New York Times followed the headline with “..advisory panel recommended.. Avandia…should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.”

Hmmm…, what did the FDA advisory committee actually do? There were a number of questions asked of the 33 members, but a key question on what should be done:

12 — withdraw the product from the market

10 — keep on the market with serious warnings

7 – keep on the market with some warnings

3 – keep on the market with no change

1 — abstain

Clearly, a divided opinion (20 keep in some fashion, 12 withdraw) that appears to mirror the divided opinion presented by the FDA in their briefing materials. FDA’s Margaret Hamburg has indicated that she will be the final decision maker since the review division is divided.

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